Hepatitis B Immune Globulin (HBIg) to Restore Immune Control in People With Chronic Hepatitis B
Status:
Recruiting
Trial end date:
2022-05-30
Target enrollment:
Participant gender:
Summary
Background:
Hepatitis B is a viral infection of the liver. When the immune system tries to clear
hepatitis B, it damages the liver. Eventually, the immune system gets exhausted fighting the
virus. Researchers want to see if giving large doses of an antibody (HBIg) with the drug
peginterferon will boost the immune system in people with this disease.
Objectives:
To observe the effect of large doses of antibody against the hepatitis B surface antigen on
the immune response to the virus. To see if removing hepatitis B surface antigen from the
blood enhances the action of peginterferon.
Eligibility:
Adults ages 18 and older with hepatitis B
Design:
Participants will be screened twice with a medical history, physical exam, and blood and
urine tests.
Participants will be randomly put in one of two groups. All participants will get
peginterferon for 24 weeks. One group will first get HBIg for 12 weeks.
Participants in the combination group will have a 4-day clinic stay. They will have:
Repeats of screening tests
Eye exam
Liver ultrasound
The first dose of HBIg by IV over 2 hours
These participants will get HBIg at the clinic up to 8 times over 12 weeks then start the
peginterferon.
All participants will get peginterferon for 24 weeks. They will get it by injection under the
skin once a week. They may do this themselves. They will keep a drug diary. They will have 5
visits to assess response and monitoring for safety..
After stopping the study drug, participants will have 4 follow-up visits over 36 weeks. They
will repeat screening tests and have 1 liver ultrasound.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)